Corneal Edema, Fuchs Endothelial Dystrophy
Conditions
Brief summary
Descemet's stripping with endothelial keratoplasty (DSEK) is a cornea-sparing transplant technique that replaces only the diseased endothelial cell layer of the patient's cornea. The DSEK technique requires lamellar dissection of the donor tissue prior to implantation in the patient's eye. The surgeon usually dissects the donor cornea with a microkeratome at the time of surgery. Recently some eye banks have begun to pre-cut the donor graft as an added service. The purpose of this study was to compare outcomes with eye bank pre-cut and surgeon-dissected donor grafts for DSEK.
Interventions
PROCEDUREDescemet's stripping endothelial keratoplasty
Small incision corneal transplant procedure to treat dysfunctional endothelium.
Sponsors
North Carolina Lion's Eye Bank
Price Vision Group
Cornea Research Foundation of America
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* candidate for Descemet's stripping with endothelial keratoplasty * at least 21 years old * willing and able to return for scheduled follow-up visits * reads and signs Informed Consent document
Exclusion criteria
* visual acuity of less than 20/400 in fellow eye * known sensitivity to planned study concomitant medications
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial Cell Loss | 6 months after grafting | Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100. |
Secondary
| Measure | Time frame |
|---|---|
| Best Corrected Vision | 6 months and 1 year after grafting |
| Graft Dislocation | 1 day to 1 month after grafting |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Eye Bank Pre-cut Grafts An Eye bank pre-cut the donor grafts used for the corneal transplant procedures. | 20 |
| Surgeon Dissected Grafts The surgeon dissected the donor grafts used for the transplant procedures. | 20 |
| Total | 40 |
Baseline characteristics
| Characteristic | Eye Bank Pre-cut Grafts | Surgeon Dissected Grafts | Total |
|---|---|---|---|
| Age, Continuous | 70 years STANDARD_DEVIATION 12 | 72 years STANDARD_DEVIATION 13 | 71 years STANDARD_DEVIATION 12 |
| Region of Enrollment United States | 20 participants | 20 participants | 40 participants |
| Sex: Female, Male Female | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Male | 8 Participants | 7 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 4 / 20 | 2 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 |
Outcome results
Primary
Endothelial Cell Loss
Endothelial cell density was measured by specular or confocal microscopy. Percent cell loss was calculated by subtracting the graft endothelial cell density measured at 6 months from the baseline donor endothelial cell density and dividing by the baseline donor endothelial cell density then multiplying by 100.
Time frame: 6 months after grafting
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Eye Bank Pre-cut Grafts | Endothelial Cell Loss | 28 percentage of endothelial cell loss | Standard Deviation 20 |
| Surgeon Dissected Grafts | Endothelial Cell Loss | 36 percentage of endothelial cell loss | Standard Deviation 18 |
p-value: 0.1paired difference t-test
Secondary
Best Corrected Vision
Time frame: 6 months and 1 year after grafting
Secondary
Graft Dislocation
Time frame: 1 day to 1 month after grafting